On May 1, 2025, the Royal Gazette published the FDA Announcement Re: The Control of Health Products, signaling a major step forward in Thailand’s regulatory framework. The regulation, which will come into force on June 1, 2025, represents a significant advancement in the integration of customs and health product controls through the Thailand National Single Window (Thai NSW) system. This reform reflects enhanced cooperation between the Food and Drug Administration (FDA) and the Thai Customs Department, aiming to streamline compliance procedures, reduce duplication, and enhance accuracy in the import and export of regulated health products.
Repeal and Replacement of the 2017 Regulation
This announcement repeals and replaces the 2017 version of the same regulation. The updated regulation establishes a mandatory, fully electronic customs system for health products, promoting efficiency and centralized control. The scope covers a broad range of regulated items, including:
✓ Pharmaceuticals
✓ Medical devices
✓ Food and dietary supplements
✓ Cosmetics
✓ Herbal products
✓ Hazardous substances
Alignment with the Thai Customs Controlled Goods Database
A central feature of this regulatory overhaul is the integration of FDA-regulated products into the Thai Customs Controlled Goods Database. This alignment provides importers, exporters, and customs brokers with a unified reference point for classification and licensing requirements.
This harmonized database eliminates ambiguity by clearly indicating whether a product is subject to FDA control, reducing the risk of classification errors and procedural delays.
Key Regulatory Features
1. Defined Terms and Scope
The regulation introduces clearly defined terms to facilitate consistent interpretation and application across agencies. (See Figure 1)
| No. | Terms | Definitions |
| 1 | Health Products | Products regulated by the FDA, including medicine, food, medical equipment, cosmetics, narcotics, psychotropic substances, hazarous household items, herbs |
| 2 | Govermental authorities | The FDA or other governmental units assigned by the FDA to issue approval or documents (electronic or otherwise) for import/export purposes. |
| 3 | Customs Tariff Code and Statistical Code | The 8-digit classification code (Chapter, Heading, Subheading) and the 3-digit statistical code used by Thai Customs. |
| 4 | List of goods | The name and description of products based on the customs tariff code and statistical code. |
| 5 | License | Any document required by law to be submitted to the FDA before or when seeking approval (e.g. license, certificate, notification, registration). |
| 6 | License per invoice | A document issued by the FDA to link electronic data for import acknowledgment; not considered a legal license under FDA regulations. |
| 7 | Importer | The owner, possessor, or stakeholder of health products from the time of import until delivery is completed and no longer under Customs’ custody. |
| 8 | Exporter | The owner, possessor, or stakeholder of health products from the time products enter Customs’ custody until they are exported out of the country. |
| 9 | Connection of electronic information | The data link between government and/or private electronic systems for import/export, via the Thai National Single Window (Thai NSW). |
Figure 1. Definitions.
2. Electronic Information Integration
Entities importing or exporting FDA-regulated products must now interface with the Thai Customs electronic system via Thai NSW. Product verification, licensing, and documentation must be processed digitally.
3. Licensing and Pre-Clearance Procedures
Importers are required to submit electronic reports via the Thai NSW system prior to customs clearance. Each import transaction involving controlled goods must include:
✓ An itemized report of all health products per invoice
✓ Proper classification using customs codes
✓ A valid FDA license, including a unique “License Per Invoice” data reference
This digital reference is mandatory and facilitates the customs clearance process.
4. Treatment of Unlisted Health Products
In cases where products fall under the FDA’s regulatory scope but are not listed in the Controlled Goods Database, importers are still obligated to obtain a license before customs processing can proceed.
5. Procedural Exceptions and Special Cases
The regulation outlines specific scenarios where exemptions or alternative procedures apply. (See Figure 2) These may include exemptions under certain thresholds, sample shipments, or special administrative provisions.
| No. | Exempt type | What it is | Requirement |
| 1 | EXEMPT 2 | Exemption due to the purpose of import not requiring a license, covering specific types of goods. | No license required if the imported goods fall under the following: 1. Medicine used in scientific labs (excluding narcotics and hazardous substances under other agencies’ control). 2. Goods exempted by the Department of Public Health (excluding narcotics and psychotropic substances). 3. Goods for use in sports or sporting activities. 4. Household/public-use hazardous substances for disease control, cleaning, etc., excluding insecticide ingredients. 5. Ingredients for use in non-health product industries, excluding medicine, narcotics, or psychotropics. |
| 2 | EXEMPT 3 | Exemption due to the goods being controlled under other laws and already approved by other government agencies. | No license required because the goods are licensed by other authorities, including: 1. Hazardous substances under agencies like Dept. of Agriculture, Fisheries, Livestock, Industrial Works, Energy, etc. 2. Food ingredients used in making animal food with licenses from other agencies. |
| 3 | EXEMPT 00 | Exemption for spare parts and components not considered medical devices, and equipment/software used only for research. | No license required for: 1. Component materials not defined as medical equipment but used as medical device parts (excluding narcotic-controlled parts). 2. Spare parts not considered medical devices under the law. 3. Equipment/software for research only, not for clinical/medical use under the Medical Device Act. |
| 4 | EXEMPT 99 | Exemption when the importer cannot provide a health product import notification, but has already received approval. | No license required but: – The importer must submit a clarification letter and all related documents at the checkpoint. – FDA must review the shipping documents and check the goods list before release. – Exception: Not applicable for ingredients intended for use in herbal products under the Herbal Act. |
| 5 | EXEMPT 100 | Exemption when the government’s license-issuing system is not working, based on a case-by-case basis. | No license required, but: – In the license/permit number field, note that the system was not functioning. – FDA must check the shipping documents and the goods list before release from custody. |
| 6 | Other goods not classified as health products | Goods in the customs database that are not health products and not subject to control or license. | Importer must record license information in the customs computer system. |
Figure 2.Certain Exemptions and Specific Procedures.
Compliance Implications for Businesses
Companies dealing in regulated health products must now adapt to a new compliance framework. Key steps include:
✓ Accurate product classification using harmonized tariff codes and statistical codes
✓ Pre-verification of FDA licensing requirements
✓ Digital alignment with Thai NSW for customs submissions
✓ Risk assessment to identify products near regulatory classification thresholds
✓ Pre-licensing and documentation review before shipment
Failure to comply may result in clearance delays, penalties, or rejected entries, affecting supply chain continuity and financial performance.
Legal and Advisory Support
Given the complexity of overlapping product classifications and evolving customs-FDA coordination, legal counsel is highly recommended. Expert support can assist with:
✓ Product classification and verification against FDA-controlled lists
✓ License applications and Thai NSW submissions
✓ Preparation of “License Per Invoice” documentation
✓ Drafting exemption letters (e.g., Exempt 99 clarification letters)
✓ Representation in correspondence with FDA or Thai Customs authorities
This is particularly important for businesses involved in the trade of medical devices, cosmetics, food supplements, raw materials, or borderline products.
Conclusion
The new regulation underscores Thailand’s commitment to digital trade facilitation and regulatory efficiency, while also introducing stricter compliance mechanisms for health-related imports and exports. Businesses should act promptly to align their internal compliance systems and supply chains with the updated framework to mitigate risk and ensure operational continuity.
For tailored support, regulatory insights, or legal assistance in navigating these changes, our team at Mahanakorn Partners Group is available to assist. Contact us at [email protected]